Lilly to Present New Data on Olumiant® (baricitinib) in Rheumatoid Arthritis and Taltz® (ixekizumab) in Psoriatic Arthritis at the Annual European Congress of Rheumatology (EULAR 2017)
Lilly will also present six abstracts evaluating Taltz® (ixekizumab) for the treatment of psoriatic arthritis (PsA), including two oral presentations highlighting data from two Phase 3 studies (SPIRIT-P1 and SPIRIT-P2). Additionally, Lilly will present two abstracts from its ongoing research to advance the understanding of rheumatologic diseases. One abstract is focused on the relationship between the degree of skin involvement and joint activity in patients with PsA based on information from the Corrona® registry, and the other abstract is on the symptomology, disease status and remission rate of non-radiographic axial spondyloarthritis and ankylosing spondylitis patients in "Rheumatoid arthritis, psoriatic arthritis and psoriasis are chronic, debilitating diseases that significantly impact the physical wellbeing of millions of people worldwide, many of whom are not currently achieving their treatment goals with existing therapies," said Studies, as well as dates and times of the data sessions, are highlighted below. Olumiant Data PUBLISHED ONLY - NO PRESENTATION Taltz Data PUBLISHED ONLY - NO PRESENTATION Additional Data PUBLISHED ONLY - NO PRESENTATION Baricitinib was approved in INDICATIONS AND USAGE FOR OLUMIANT Therapeutic indications IMPORTANT SAFETY INFORMATION FOR OLUMIANT CONTRAINDICATIONS SPECIAL WARNINGS AND PRECAUTIONS FOR USE Infections Tuberculosis Haematological Abnormalities The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. Viral Reactivation Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant. Patients with evidence of active hepatitis B or C infection were excluded from clinical trials. Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate. Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA. If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted. Vaccination Lipids Hepatic transaminase elevations Malignancy Laboratory Monitoring Immunosuppressive Medicinal Products ADVERSE REACTIONS Undesirable Effects: Summary of safety profile Please see Summary of Product Characteristics. INDICATIONS AND USAGE FOR TALTZ Taltz® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. IMPORTANT SAFETY INFORMATION FOR TALTZ CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Infections Pre-Treatment Evaluation for Tuberculosis Hypersensitivity Inflammatory Bowel Disease Immunizations ADVERSE REACTIONS Most common adverse reactions ( > 1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device. IX HCP ISI 18JAN2017 About Rheumatoid Arthritis About Olumiant In About Active Psoriatic Arthritis About Taltz® Lilly has filed a supplemental Biologics License Application (sBLA) with the About About Follow @Incyte on Twitter at https://twitter.com/Incyte. P-LLY This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis, and reflects Lilly's and i WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed: May, 16, 2017) ii iii iv McWilliams DF, Kiely PDW, Young A, Walsh DA. Baseline factors predicting change from the initial DMARD treatment during the first 2 years of rheumatoid arthritis: experience in the ERAN inception cohort. BMC Musculoskeletal Disorders. 2013;14:1-7. v About psoriatic arthritis. vi What is psoriatic arthritis? vii Classification of psoriatic arthritis.
Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Olumiant may be used as monotherapy or in combination with methotrexate.
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy.
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo. In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy. The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections. If an infection develops, the patient should be monitored carefully and Olumiant therapy should be temporarily interrupted if the patient is not responding to standard therapy. Olumiant treatment should not be resumed until the infection resolves.
Patients should be screened for tuberculosis (TB) before starting Olumiant therapy. Olumiant should not be given to patients with active TB. Anti-TB therapy should be considered prior to initiation of Olumiant in patients with previously untreated latent TB.
Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in less than 1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies. Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs. If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted until the episode resolves.
No data are available on the response to vaccination with live or inactivated vaccines in patients receiving baricitinib. Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended. International treatment guidelines on vaccination in rheumatoid arthritis patients should be followed when varicella zoster vaccination is considered prior to treatment with Olumiant.
Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo. Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy. Lipid parameters should be assessed approximately 12 weeks following initiation of Olumiant therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1% of patients in clinical trials. In treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, Olumiant should be temporarily interrupted until this diagnosis is excluded.
The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis. Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib. Long-term safety evaluations are ongoing.
Please refer to the SmPC for laboratory measures and monitoring guidance.
Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded. Data concerning use of baricitinib with potent immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and caution should be exercised when using such combinations.
The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2% of patients treated with Olumiant monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6%), upper respiratory tract infections (14.7%) and nausea (2.8%). Infections reported with Olumiant treatment included Herpes zoster.
Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.
Serious hypersensitivity reactions, including anaphylaxis, angioedema and urticaria, have been reported with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease.
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide suffer from RA.i Approximately three times as many women as men have the disease.ii Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs (NSAIDs), oral conventional disease-modifying antirheumatic drugs (cDMARDs) - such as methotrexate, the current standard of care, and injectable and intravenous biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.iii Despite current treatment options, many patients do not reach their therapeutic goals or are not able to achieve sustained remission.iv There remains an important need to provide additional
treatment options to improve overall patient care.
Olumiant® (baricitinib) is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.
Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause swelling, stiffness and pain in and around the joints, nail changes and impaired physical function.v It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.vi Typically, psoriatic arthritis affects peripheral joints in the arms and legs (elbows, wrists, hands and feet), but can also affect joints in the axial skeleton (spine, hips and shoulders).vii If left untreated, PsA can cause permanent joint damage.v Additionally, up to 30 percent of people with psoriasis also develop PsA.v
Taltz® (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
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